- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03770923
Effect of Some Drugs on Rheumatoid Arithritis Activity
December 7, 2018 updated by: Sherief Abd-Elsalam
Clinical Study Evaluating the Effect of Histamine 1 Receptor Antagonist and Leukotreine Receptor Antagonist on Patients With Rheumatoid Arithritis
Effect of Some Drugs on Rheumatoid Arithritis Activity.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The study aims at evaluating the effect of Some Drugs on Rheumatoid Arithritis Activity.
Study Type
Interventional
Enrollment (Anticipated)
75
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tanta, Egypt, 35111
- Recruiting
- Sherief Abd-Elsalam
-
Contact:
- Fedaa Kotkata, Msc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Rheumatoid arthritis
Exclusion Criteria:
- liver or renal disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No intervention
|
|
Active Comparator: Rupatadine
Rupatadine 10 mg once daily.
|
Rupatadine 10 mg daily
|
Active Comparator: Montelukast
Montelukast 10 mg daily
|
Montelukast 10 mg daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
se level of IL-17
Time Frame: 6 months
|
change in level of IL-17
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sahar K Hegazy, Prof, Head of clinical Pharmacy Department
- Study Director: Tarek M Mostafa, Prof, Clinical pharmacy Department- Tanta University
- Study Chair: Salwa E Abd El-Ghany, Prof, Rheumatology Dept. - Tanta University
- Study Chair: Fedaa AK Kotkata, Msc, Clinical pharmacy Department-Tanta University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Anticipated)
October 1, 2026
Study Completion (Anticipated)
October 1, 2027
Study Registration Dates
First Submitted
December 7, 2018
First Submitted That Met QC Criteria
December 7, 2018
First Posted (Actual)
December 10, 2018
Study Record Updates
Last Update Posted (Actual)
December 10, 2018
Last Update Submitted That Met QC Criteria
December 7, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Anti-Asthmatic Agents
- Respiratory System Agents
- Leukotriene Antagonists
- Hormone Antagonists
- Cytochrome P-450 CYP1A2 Inducers
- Cytochrome P-450 Enzyme Inducers
- Montelukast
Other Study ID Numbers
- Rheumatoid Arithritis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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